FDA Seeks To Trim Radiation Exposure

The U.S. Food and Drug Administration (FDA) plans to issue requirements to manufacturers of computed tomography (CT) and fluoroscopic devices to incorporate safeguards into the design of the machines to reduce exposure to radiation, according to the agency. A public meeting has been planned for March 30-31 to seek input.

CT, nuclear medicine studies and fluoroscopy use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography, according to the agency, which also noted that CT, nuclear medicine and fluoroscopy can increase a person’s lifetime risk of developing cancer.

“The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The goal of FDA’s initiative is to support the benefits associated with medical imaging while minimizing the risks.”

Through the FDA’s regulatory oversight of medical imaging devices, such as CT scanners, and through collaboration with other federal agencies and healthcare professional groups, the FDA is advocating the adoption of two principles of radiation protection: appropriate justification of the radiation procedure and optimization of the radiation dose used during each procedure.

Potential requirements include that these devices display, record, and report equipment settings and radiation dose, an alert for users when the dose exceeds a diagnostic reference level (the optimal dose for most patients), training for users, and a requirement that devices be able to capture and transmit radiation dose information to a patient’s electronic medical record and to national dose registries, the agency said.

In addition, the FDA and the Centers for Medicare and Medicaid Services are collaborating to incorporate key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals. These quality assurance practices will improve the quality of oversight and promote the safe use of advanced imaging technologies in those facilities, according to the FDA.

In addition, the agency is collaborating with other organizations to develop and disseminate a patient medical imaging history card. This tool, which will be available on the FDA’s Web site, www.fda.gov, will allow patients to track their own medical imaging histories and share them with their physicians.